Osteoarthritis, KneeNCT03699046
Evaluating the Effectiveness of Subchondroplasty for Treating Bone Marrow Lesions of the Knee
A study testing Subchondroplasty and Knee Arthroscopy, Knee Arthroscopy Alone and Subchondroplasty in people with Osteoarthritis, Knee and Arthroscopy, run by University of Calgary at 1 site in Canada.
Trial summary
The primary objective of this randomized pilot study is to evaluate whether subchondroplasty combined with knee arthroscopy is more effective at reducing knee pain and improving knee function compared to knee arthroscopy alone. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Arthroscopy, Musculoskeletal Disease
- What is being tested?
- Subchondroplasty and Knee Arthroscopy, Knee Arthroscopy Alone and Subchondroplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 18 Oct 2018to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years of age or older
- Kellgren-Lawrence grade 1-3 osteoarthritis in the affected knee
- Has experienced pain in the affected knee for at least 3 months
- Candidate for knee arthroscopy (moderate to severe symptoms, lack of response to non-operative care, and/or mechanical symptoms)
- Stable ligament exam
- No additional injuries affecting the study knee or contralateral knee
- Candidate for MRI (no pacemaker, aneurysmal clip, eye prosthesis, pregnancy, neurostimulator, implanted stimulator [e.g. diabetes pump])
- Confirmed visualization of at least 1 bone marrow lesions using T2 weighted MRI
Who cannot join
- Determined to not be a surgical candidate
- Kellgren-Lawrence grade 4 osteoarthritis
- Unable to fit in XtremeCT scanner (based on measurement at time of recruitment)
- Contraindications to MRI
- Any hardware present in either knee that could interfere with MRI signal
- Bone marrow lesion(s) caused by acute trauma prior to enrolment
Show all 27Show fewer
- Radiographic mal-alignment defined by obvious valgus > 7° or obvious varus > 7° on measured hip-knee-ankle angle
- No bone marrow lesion detected on baseline (pre-operative) MRI
- Rheumatoid arthritis
- Septic arthritis
- Reactive arthritis
- Gout
- Osteochondritis dissecans of knee resulting in significant bone loss
- Collapse of subchondral bone
- Restricted knee range of motion: passive flexion < 110° or a flexion contracture > 30°
- Ligament instability in either knee
- History of other arthropathies (e.g. sickle cell or autoimmune disease)
- History of uncontrolled diabetes: HbA1C level of 8 or higher, measured within 3 months of enrollment
- Unable to perform a functional assessment of either knee
- Current smoker or stopped smoking for less than 3 months
- History of invasive malignancy (Unless treated in the past and has had no clinical signs or symptoms of malignancy for 5 years or longer)
- Has a primary bone tumor in the knee or adjacent to the knee
- Having surgery on another part of the lower limb in addition to the study procedure
- Taking prescription pain medication other than NSAIDs or acetominophen
- Active infection or a history of joint infection
- Pursuing action through the Workers' Compensation Board - Alberta
- BMI > 40
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Denise Chan, MSc, 403-220-8944, kneeresearch@ucalgary.ca
About this study
Official title: Randomized Pilot Study Comparing the Effectiveness of Subchondroplasty Combined With Arthroscopy to Arthroscopy Alone for Treating Bone Marrow Lesions of the Knee
The primary objective of this randomized pilot study is to evaluate whether subchondroplasty combined with knee arthroscopy is more effective at reducing knee pain and improving knee function compared to knee arthroscopy alone. All knee function outcomes will be assessed at initial presentation, 3 months, 6 months, 12 months, and 24 months following surgery using validated questionnaires. Patient-reported pain will also be recorded at 2 weeks after surgery.
The secondary objective of the study is to determine whether the subchondroplasty and knee arthroscopy group has better bone quality and bone micro-architecture compared to the group receiving knee arthroscopy alone. Bone quality/micro-architecture will be evaluated at baseline, 3 months, and 12 months following surgery using Magnetic resonance imaging (MRI) and High-Resolution Peripheral Quantitative CT (HR-pQCT) imaging and at baseline, 3 months, 12 months, and 24 months after surgery using X-rays.
Read the detailed description
The investigators hypothesize that patients receiving subchondroplasty combined with arthroscopy will have reduced knee pain, improved knee function, and improved bone quality and micro-architecture compared to patients receiving arthroscopy alone who have symptomatic early osteoarthritis with the presence of at least one BML observed on MRI.
Patients who provide informed consent to enroll in the study will be scheduled for knee surgery and randomized to receive subchondroplasty and arthroscopy or arthroscopy alone. Knee function outcomes will be assessed at initial presentation, 3 months, 6 months, 12 months, and 24 months following surgical intervention. Patient-reported pain will also be recorded at 2 weeks following surgical intervention. The evaluation of bone quality and micro-architecture will occur at baseline, 3 months, and 12 months following surgical intervention. X-rays will also be evaluated at the 24-month time-point.
- Conditions
- Osteoarthritis, Knee, Arthroscopy, Musculoskeletal Disease, Bone Marrow Edema, Subchondral Bone Edema, Knee Osteoarthritis
- Being tested
- Subchondroplasty and Knee Arthroscopy, Knee Arthroscopy Alone, Subchondroplasty
- Keywords
- Bone Marrow Lesion, Subchondroplasty, Knee Function, Knee Pain, Bone Quality, Bone Micro-architecture
- Medical subject headings
- Osteoarthritis, Knee, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subchondroplasty and Knee ArthroscopyProcedure or surgery
Subchondroplasty® (SCP®) is a procedure performed along with minimally-invasive arthroscopy. The bone marrow lesion(s) will be located using pre-operative MRI combined with fluoroscopy (intra-operative X-ray) and a small, drillable AccuPort® Delivery Cannula will be placed in the appropriate position. The cannula will then be drilled into the bone marrow lesion(s) and a flowable, synthetic, calcium phosphate bone substitute (AccuFill® Bone Substitute Material, Zimmer Biomet) will be injected into the lesion(s). The calcium phosphate bone substitute will then harden, improve the structural integrity of the damaged subchondral bone, and will gradually be resorbed and replaced with new bone.
Knee Arthroscopy AloneProcedure or surgery
Knee arthroscopy is a surgical procedure that involves the orthopaedic surgeon making small incisions in the knee and then inserting a small camera into the joint. Following the insertion of the camera, multiple procedures can be completed to treat a number of different conditions such as repair or partial/complete removal of the meniscus, debridement, lavage, removal of a loose body among others.
SubchondroplastyBiological
Also called SCP® (Zimmer)
Subchondroplasty® (SCP®) is a procedure performed along with minimally-invasive arthroscopy. The specific biological component of the procedure involves the injection of the AccuFill® Bone Substitute Material (Zimmer Biomet), which is a a flowable, synthetic, calcium phosphate bone substitute, into the bone marrow lesion(s).
| Study group | Role | What they receive |
|---|---|---|
| Subchondroplasty and Knee Arthroscopy | Active comparator | Patients randomized to the Subchondroplasty and Knee Arthroscopy group will receive the subchondroplasty procedure before or after knee arthroscopy that will be completed based on current standard of care guidelines. Receives: Procedure: Subchondroplasty and Knee Arthroscopy; Biological: Subchondroplasty |
| Knee Arthroscopy Alone | Sham comparator | Patients randomized to the Knee Arthroscopy Alone group will receive the knee arthroscopy that will be completed based on current standard of care guidelines. Receives: Procedure: Knee Arthroscopy Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire scores
The primary outcome measure will be the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire scores for knee pain and knee function.
The KOOS questionnaire consists of 5 different sub-scales including Symptoms (7 questions), Pain (9 questions), Activities of Daily Living (17 questions), Sports/Recreation (5 questions), and Quality of Life (4 questions). A normalized score from 0-100 (100 indicates no problems/symptoms and 0 indicates extreme problems/symptoms) is calculated for each sub-scale individually.
Measured: Baseline (pre-surgery), 3 months, 6 months, 12 months, 24 months post-surgery.
Secondary outcomes (5)
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form scores
Knee pain and function will also be evaluated using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form scores.
The IKDC includes three different domains including Symptoms (7 questions), Sports Activities (2 questions, 1 multi-part question), and Function (1 multi-part question). A total score from 0-100 (100 indicates no problems/symptoms and 0 indicates extreme problems/symptoms) is calculated.
Measured: Baseline (pre-surgery), 3 months, 6 months, 12 months, 24 months post-surgery.
Change in Patient-Reported Pain scores on the Visual Analog Scale (VAS)
Knee pain will also be evaluated using the Visual Analog Scale (VAS) scores for patient-reported pain.
The Visual Analog Scale (VAS) consists of a 10 cm long straight line that starts from the lowest value of 0 (no pain) at one end, and the highest value of 10 (worst pain possible) at the other. Patients are asked to mark a place on the line that represents the severity of their pain. Scores are recorded in millimetres from 0-100 with 0 indicating no pain and 100 indicating the worst pain possible.
Measured: Baseline (pre-surgery), 2 weeks, 3 months, 6 months, 12 months, 24 months post-surgery.
Change in bone quality/micro-architecture evaluated using magnetic resonance imaging (MRI)
The bone quality and micro-architecture of the bone marrow lesion(s) in the knee, and the knee overall, will be evaluated using magnetic resonance imaging (MRI). MRI will be used to identify the presence of bone marrow lesion(s) in the knee at baseline before surgery using a T2 weighted fat-suppression sequence and evaluate the bone marrow lesion(s) post-surgery.
Measured: Baseline (pre-surgery), 3 months, 12 months post-surgery
Change in bone quality/micro-architecture evaluated using High-Resolution Peripheral Quantitative CT (HR-pQCT) imaging
The bone quality and micro-architecture of the bone marrow lesion(s) in the knee, and the knee overall, will also be evaluated using High-Resolution Peripheral Quantitative CT (HR-pQCT) imaging. HR-pQCT imaging will be used to evaluate the bone micro-architecture of the knee and the bone marrow lesion(s) before and after surgery.
Measured: Baseline (pre-surgery), 3 months, 12 months post-surgery
Change in bone quality/micro-architecture evaluated using X-rays
The bone quality and micro-architecture of the bone marrow lesion(s) in the knee, and the knee overall, will also be evaluated using X-ray. X-ray imaging will be used to evaluate bone quality and osteoarthritis status before and after surgery.
Measured: Baseline (pre-surgery), 3 months, 12 months, 24 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start18 Oct 2018
- Primary completion31 Mar 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The control group will be patients receiving knee arthroscopy alone and the intervention group will be patients receiving subchondroplasty and knee arthroscopy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- McCaig Institute for Bone and Joint Health - Centre for Mobility and Joint Health
- Responsible party
- Principal investigator, Alexander Rezansoff, University of Calgary
- Investigators
- Alexander Rezansoff, MD, FRCSC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699046
- Sponsor's protocol ID
- REB18-0650
- Status last verified
- Mar 2020
- First submitted
- 3 Oct 2018
- Last updated
- 31 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Study Comparing the Effectiveness of Subchondroplasty Combined With Arthroscopy to Arthroscopy Alone for Treating Bone Marrow Lesions of the Knee
- ClinicalTrials.gov ID
- NCT03699046
- Acronym / sponsor ID
- REB18-0650
- Conditions
- Osteoarthritis, Knee, Arthroscopy, Musculoskeletal Disease, Bone Marrow Edema, Subchondral Bone Edema, Knee Osteoarthritis
- Keywords
- Bone Marrow Lesion, Subchondroplasty, Knee Function, Knee Pain, Bone Quality, Bone Micro-architecture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- McCaig Institute for Bone and Joint Health - Centre for Mobility and Joint Health
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this randomized pilot study is to evaluate whether subchondroplasty combined with knee arthroscopy is more effective at reducing knee pain and improving knee function compared to knee arthroscopy alone. All knee function outcomes will be assessed at initial presentation, 3 months, 6 months, 12 months, and 24 months following surgery using validated questionnaires. Patient-reported pain will also be recorded at 2 weeks after surgery.
The secondary objective of the study is to determine whether the subchondroplasty and knee arthroscopy group has better bone quality and bone micro-architecture compared to the group receiving knee arthroscopy alone. Bone quality/micro-architecture will be evaluated at baseline, 3 months, and 12 months following surgery using Magnetic resonance imaging (MRI) and High-Resolution Peripheral Quantitative CT (HR-pQCT) imaging and at baseline, 3 months, 12 months, and 24 months after surgery using X-rays.
Detailed description
The investigators hypothesize that patients receiving subchondroplasty combined with arthroscopy will have reduced knee pain, improved knee function, and improved bone quality and micro-architecture compared to patients receiving arthroscopy alone who have symptomatic early osteoarthritis with the presence of at least one BML observed on MRI.
Patients who provide informed consent to enroll in the study will be scheduled for knee surgery and randomized to receive subchondroplasty and arthroscopy or arthroscopy alone. Knee function outcomes will be assessed at initial presentation, 3 months, 6 months, 12 months, and 24 months following surgical intervention. Patient-reported pain will also be recorded at 2 weeks following surgical intervention. The evaluation of bone quality and micro-architecture will occur at baseline, 3 months, and 12 months following surgical intervention. X-rays will also be evaluated at the 24-month time-point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The control group will be patients receiving knee arthroscopy alone and the intervention group will be patients receiving subchondroplasty and knee arthroscopy.
| Arm | Type | Receives |
|---|---|---|
| Subchondroplasty and Knee Arthroscopy | Active comparator | Procedure: Subchondroplasty and Knee Arthroscopy, Biological: SubchondroplastyPatients randomized to the Subchondroplasty and Knee Arthroscopy group will receive the subchondroplasty procedure before or after knee arthroscopy that will be completed based on current standard of care guidelines. |
| Knee Arthroscopy Alone | Sham comparator | Procedure: Knee Arthroscopy AlonePatients randomized to the Knee Arthroscopy Alone group will receive the knee arthroscopy that will be completed based on current standard of care guidelines. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 40 years of age or older
- Kellgren-Lawrence grade 1-3 osteoarthritis in the affected knee
- Has experienced pain in the affected knee for at least 3 months
- Candidate for knee arthroscopy (moderate to severe symptoms, lack of response to non-operative care, and/or mechanical symptoms)
- Stable ligament exam
Key exclusion criteria (27 listed)
- Determined to not be a surgical candidate
- Kellgren-Lawrence grade 4 osteoarthritis
- Unable to fit in XtremeCT scanner (based on measurement at time of recruitment)
- Contraindications to MRI
- Any hardware present in either knee that could interfere with MRI signal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subchondroplasty and Knee ArthroscopySubchondroplasty® (SCP®) is a procedure performed along with minimally-invasive arthroscopy. The bone marrow lesion(s) will be located using pre-operative MRI combined with fluoroscopy (intra-operative X-ray) and a small, drillable AccuPort® Delivery Cannula will be placed in the appropriate position. The cannula will then be drilled into the bone marrow lesion(s) and a flowable, synthetic, calcium phosphate bone substitute (AccuFill® Bone Substitute Material, Zimmer Biomet) will be injected into the lesion(s). The calcium phosphate bone substitute will then harden, improve the structural integrity of the damaged subchondral bone, and will gradually be resorbed and replaced with new bone. | Procedure or surgery | Subchondroplasty and Knee Arthroscopy |
| Knee Arthroscopy AloneKnee arthroscopy is a surgical procedure that involves the orthopaedic surgeon making small incisions in the knee and then inserting a small camera into the joint. Following the insertion of the camera, multiple procedures can be completed to treat a number of different conditions such as repair or partial/complete removal of the meniscus, debridement, lavage, removal of a loose body among others. | Procedure or surgery | Knee Arthroscopy Alone |
| SubchondroplastyAlso: SCP® (Zimmer)Subchondroplasty® (SCP®) is a procedure performed along with minimally-invasive arthroscopy. The specific biological component of the procedure involves the injection of the AccuFill® Bone Substitute Material (Zimmer Biomet), which is a a flowable, synthetic, calcium phosphate bone substitute, into the bone marrow lesion(s). | Biological | Subchondroplasty and Knee Arthroscopy |
Primary outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire scores
Time frame: Baseline (pre-surgery), 3 months, 6 months, 12 months, 24 months post-surgery.
The primary outcome measure will be the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire scores for knee pain and knee function. The KOOS questionnaire consists of 5 different sub-scales including Symptoms (7 questions), Pain (9 questions), Activities of Daily Living (17 questions), Sports/Recreation (5 questions), and Quality of Life (4 questions). A normalized score from 0-100 (100 indicates no problems/symptoms and 0 indicates extreme problems/symptoms) is calculated for each sub-scale individually.
5 secondary outcomes
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form scores
Time frame: Baseline (pre-surgery), 3 months, 6 months, 12 months, 24 months post-surgery.
Change in Patient-Reported Pain scores on the Visual Analog Scale (VAS)
Time frame: Baseline (pre-surgery), 2 weeks, 3 months, 6 months, 12 months, 24 months post-surgery.
Change in bone quality/micro-architecture evaluated using magnetic resonance imaging (MRI)
Time frame: Baseline (pre-surgery), 3 months, 12 months post-surgery
Change in bone quality/micro-architecture evaluated using High-Resolution Peripheral Quantitative CT (HR-pQCT) imaging
Time frame: Baseline (pre-surgery), 3 months, 12 months post-surgery
Change in bone quality/micro-architecture evaluated using X-rays
Time frame: Baseline (pre-surgery), 3 months, 12 months, 24 months post-surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Rezansoff, MD, FRCSC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subchondroplasty and Knee Arthroscopy, Knee Arthroscopy Alone and Subchondroplasty in people with Osteoarthritis, Knee and Arthroscopy, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire scores (time frame: Baseline (pre-surgery), 3 months, 6 months, 12 months, 24 months post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.